MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® EXTRACTION TOOL, CAPTURING ROD; INTRAMED FIXATN ROD AND ACCESS

Model Number	GALILEO® EXTRACTION TOOL, CAPTURING ROD
Medical Device Problem Codes	Defective Device (2588); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 04/01/2024, it was reported by a sales representative via sems-06529172 that an 0857-100 galileo extraction tool was damaged during the case.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged 0857-100 batch 221019 was received for investigation.The device arrived stuck inside the part number 1099-0090 batch 212625.Functional testing was not performed due to the device arrived stuck inside the part number 1099-0090.Upon visual inspection, damage to the shaft and the threaded tip was observed.It was also noted that the device was bent.The most likely cause(s) of the reported failure are user error, misaligned insertion, or excessive force during use.
Event or Problem Description
On (b)(6) 2024, during device evaluation of the returned device, it was found that the 0857-100 was stuck inside a 1099-090 galileo lag screw, right, ø10.5mmx90mm.

• Brand Name: GALILEO® EXTRACTION TOOL, CAPTURING ROD
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19179675
• Report Number: 1220246-2024-02350
• Device Sequence Number: 12570648
• Product Code: HSB
• UDI-Device Identifier: 00848665030891
• UDI-Public: 00848665030891
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GALILEO® EXTRACTION TOOL, CAPTURING ROD
• Device Catalogue Number: 0857-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown